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Virtual Reality Approach in Subacromial Impingement Syndrome

Primary Purpose

Shoulder Impingement Syndrome, Virtual Reality, Rehabilitation

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Game Based Virtual Reality Exercises
Conventional Physiotherapy and Rehabilitation
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring Subacromial Impingement Syndrome, Physiotherapy and Rehabilitation, Virtual Reality, Technologic Rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Volunteered to participate in the study
  • Aged 18-65 years,

Exclusion Criteria:

  • Any visual or hearing problem,
  • Other neurological, orthopedic or rheumatic problems that may restrict shoulder motion or cause pain,
  • Having a physical disability or uncontrolled chronic systemic disease,
  • Major trauma,
  • Treatment for shoulder problems within the last 6 months,
  • History of epileptic attacks

Sites / Locations

  • Cadde Tıp Merkezi - Cadde Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control Group

Study Group

Arm Description

Number of participants in this group is anticipated to be 20. Conventional physiotherapy and rehabilitation methods will be applied to this group. The conventional program includes the application of Transcutaneous Electrical Nerve Stimulation (TENS), cold pack, therapeutic ultrasound, Codman Exercises, Wand exercises, shoulder wheel exercises, finger ladder exercises, strengthening exercises with elastic band and capsule stretching.

Number of participants in this group is anticipated to be 20. Participants in this group will be receiving conventional physiotherapy and rehabilitation methods and 10 minutes of exercise with the game-based virtual reality system (USE-IT). In the USE-IT system two games will be played for 5 minutes each.

Outcomes

Primary Outcome Measures

Change in range of motion from baseline to week 4
The range of motion of the joints in the upper extremities will be measured using the universal goniometer before and after the treatment.
Change in level of pain from baseline to week 4
Level of Pain will be assessed with Visual Analogue Scale (VAS). It is widely used among the methods of measuring the severity of pain. Scale is a 10 cm ruler, participants will mark the level of pain between 0-10 cm, 0 would means ''no pain'' and 10 would means ''worst possible pain''.
Change in disability of the upper extremity from baseline to week 4
Disability of the upper extremities will be assessed with 'The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire'. It is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The questionnaire was designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time.
Change in quality of shoulder function from baseline to week 4
Quality of function of the shoulder will be assessed with Constant-Murley Score. It is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. Pain (15 points), daily living activities (20 points), active range of motion (40 points) and force (25 points) parameters, including a total of 100 points system. The total Constant score is classified as excellent (30 <), good (21 - 30), medium (11 - 20) and weak (<11).
Change in muscle strength from baseline to week 4
The muscle strength of shoulder flexion, abduction, adduction, external and internal rotation movements will be evaluated by using the Baseline Push-Pull (New York) dynamometer. Results will be calculated in kg (1 lb = 0.454 kg). The patient's arm will be stabilized and the patient will be asked to show maximum resistance within 2 sec against the dynamometer placed and then hold it for 5 seconds at this position and power. The measurement will be repeated twice and recorded with the average of these two values.
Change in pain threshold from baseline to week 4
The pain threshold will be measured with a digital algometer device. Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure-pain threshold studies that the rate at which manual force is applied should be consistent to provide the greatest reliability.
Change in proprioception from baseline to week 4
Proprioception will be evaluated with 'Marmara Visual Auditory Joint Education Device (MarVAJED) which was developed by the Faculty of Health Sciences of Marmara University, Istanbul. This device evaluates motion deficits of joints, analyzes joint position sense, provides biofeedback support to increase joint control and also directs to controlled exercises. It analyzes the motion of the joint with the help of small sensors and transfers the data obtained to the mobile phone, tablet or computer.
Change in kinesiophobia from baseline to week 4
In the assessment of kinesiophobia 'Tampa Kinesiophobia Scale (TKS)' will be used. It is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury.
Satisfaction of the Treatment
An objective test that evaluates the satisfaction of the patient from pain status, functionality, treatment and physiotherapist after treatment will be assessed with 4 questions, and each question is given a score of 0-10 using the VAS scale. 0 means ''I am not satisfied at all'', 10 means ''I am very satisfied''.

Secondary Outcome Measures

Full Information

First Posted
April 9, 2019
Last Updated
September 3, 2020
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT03912493
Brief Title
Virtual Reality Approach in Subacromial Impingement Syndrome
Official Title
The Effectiveness of Game-Based Virtual Reality Approach in Patients With Subacromial Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of our study is to investigate the effects of game-based virtual reality exercise added to conventional physiotherapy and rehabilitation program in patients with Subacromial Impingement Syndrome (SIS). In order to evaluate its effectiveness, assessment of pain, range of motion and disability will be applied.
Detailed Description
Subacromial Impingement Syndrome (SIS) is the result of contraction of the structures passing through the subacromial area. Problems in upper limb function in people with SIS adversely affect quality of life and functional independence of the patients. Recovery of restricted daily life functions (such as dressing, personal care, eating and body care) is one of the main goals of physiotherapy and rehabilitation in SIS and currently, conventional physiotherapy and rehabilitation methods are most commonly used. The main purpose of this method is to reduce pain, increase range of motion and muscle strength. With the developing technology various virtual reality applications have begun to take place in physiotherapy and rehabilitation programs recently. These virtual reality applications are used to motivate the patient and keep their interest in the rehabilitation. In addition, the diversity of virtual reality applications is increasing day by day so that participation of the patients and the interest in the treatment can be increased. Various measurements of the user's performance can be transferred to the clinician simultaneously with these systems. Also for most of these systems exercise modes, difficulty and duration are programmable so that the training sessions can be varied. The aim of our study is to investigate the effects of game-based virtual reality exercises added to conventional physiotherapy and rehabilitation program in patients with SIS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome, Virtual Reality, Rehabilitation, Subacromial Impingement Syndrome
Keywords
Subacromial Impingement Syndrome, Physiotherapy and Rehabilitation, Virtual Reality, Technologic Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Number of participants in this group is anticipated to be 20. Conventional physiotherapy and rehabilitation methods will be applied to this group. The conventional program includes the application of Transcutaneous Electrical Nerve Stimulation (TENS), cold pack, therapeutic ultrasound, Codman Exercises, Wand exercises, shoulder wheel exercises, finger ladder exercises, strengthening exercises with elastic band and capsule stretching.
Arm Title
Study Group
Arm Type
Active Comparator
Arm Description
Number of participants in this group is anticipated to be 20. Participants in this group will be receiving conventional physiotherapy and rehabilitation methods and 10 minutes of exercise with the game-based virtual reality system (USE-IT). In the USE-IT system two games will be played for 5 minutes each.
Intervention Type
Device
Intervention Name(s)
Game Based Virtual Reality Exercises
Intervention Description
A game-based virtual reality device named USE-IT will be added to the rehabilitation program. USE-IT is a technological rehabilitation system designed by the Department of Physiotherapy and Rehabilitation at Hacettepe University. It is a smart gaming device which has been used in patients who suffer from movement loss in their upper extremities due to various neurological and orthopedic reasons.
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy and Rehabilitation
Intervention Description
The conventional physiotherapy and rehabilitation program includes the application of Transcutaneous Electrical Nerve Stimulation (TENS), cold pack, therapeutic ultrasound, Codman Exercises, Wand exercises, shoulder wheel exercises, finger ladder exercises, strengthening exercises with elastic band and capsule stretching.
Primary Outcome Measure Information:
Title
Change in range of motion from baseline to week 4
Description
The range of motion of the joints in the upper extremities will be measured using the universal goniometer before and after the treatment.
Time Frame
4 weeks
Title
Change in level of pain from baseline to week 4
Description
Level of Pain will be assessed with Visual Analogue Scale (VAS). It is widely used among the methods of measuring the severity of pain. Scale is a 10 cm ruler, participants will mark the level of pain between 0-10 cm, 0 would means ''no pain'' and 10 would means ''worst possible pain''.
Time Frame
4 weeks
Title
Change in disability of the upper extremity from baseline to week 4
Description
Disability of the upper extremities will be assessed with 'The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire'. It is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The questionnaire was designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time.
Time Frame
4 weeks
Title
Change in quality of shoulder function from baseline to week 4
Description
Quality of function of the shoulder will be assessed with Constant-Murley Score. It is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. Pain (15 points), daily living activities (20 points), active range of motion (40 points) and force (25 points) parameters, including a total of 100 points system. The total Constant score is classified as excellent (30 <), good (21 - 30), medium (11 - 20) and weak (<11).
Time Frame
4 weeks
Title
Change in muscle strength from baseline to week 4
Description
The muscle strength of shoulder flexion, abduction, adduction, external and internal rotation movements will be evaluated by using the Baseline Push-Pull (New York) dynamometer. Results will be calculated in kg (1 lb = 0.454 kg). The patient's arm will be stabilized and the patient will be asked to show maximum resistance within 2 sec against the dynamometer placed and then hold it for 5 seconds at this position and power. The measurement will be repeated twice and recorded with the average of these two values.
Time Frame
4 weeks
Title
Change in pain threshold from baseline to week 4
Description
The pain threshold will be measured with a digital algometer device. Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure-pain threshold studies that the rate at which manual force is applied should be consistent to provide the greatest reliability.
Time Frame
4 weeks
Title
Change in proprioception from baseline to week 4
Description
Proprioception will be evaluated with 'Marmara Visual Auditory Joint Education Device (MarVAJED) which was developed by the Faculty of Health Sciences of Marmara University, Istanbul. This device evaluates motion deficits of joints, analyzes joint position sense, provides biofeedback support to increase joint control and also directs to controlled exercises. It analyzes the motion of the joint with the help of small sensors and transfers the data obtained to the mobile phone, tablet or computer.
Time Frame
4 weeks
Title
Change in kinesiophobia from baseline to week 4
Description
In the assessment of kinesiophobia 'Tampa Kinesiophobia Scale (TKS)' will be used. It is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury.
Time Frame
4 weeks
Title
Satisfaction of the Treatment
Description
An objective test that evaluates the satisfaction of the patient from pain status, functionality, treatment and physiotherapist after treatment will be assessed with 4 questions, and each question is given a score of 0-10 using the VAS scale. 0 means ''I am not satisfied at all'', 10 means ''I am very satisfied''.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Volunteered to participate in the study Aged 18-65 years, Exclusion Criteria: Any visual or hearing problem, Other neurological, orthopedic or rheumatic problems that may restrict shoulder motion or cause pain, Having a physical disability or uncontrolled chronic systemic disease, Major trauma, Treatment for shoulder problems within the last 6 months, History of epileptic attacks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dilara Merve SARI, MSc, PT
Phone
+905333444601
Email
dilaramervesari@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nimet SERMENLI AYDIN, MSc, PT
Email
nimetsermenli@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berivan Beril KILIC, MSc, PT
Organizational Affiliation
Marmara University Institute of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zübeyir SARI, Assoc Prof
Organizational Affiliation
Marmara University Faculty of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Cadde Tıp Merkezi - Cadde Medical Center
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nimet Sermenli Aydin, MSc

12. IPD Sharing Statement

Plan to Share IPD
No
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Virtual Reality Approach in Subacromial Impingement Syndrome

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